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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Directive 96/54/EEC, B.1tris
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA Health Effects Test Guidelines, OPPTS 870.1000 Acute Toxicity Testing EPA 712-C- 98-189, August 1998.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Testing Methods for New Chemical Substances according to the Revised Japanese Chemical Substance Law (March 31, 1987).
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch: C02421 -1620
Purity: 98.6%

Test animals

Species:
rat
Strain:
other: rat, HanBrl: Wist (SPF)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:RCC Ltd, Laboratory Animal Services CH-4414 Fullinsdorf / Switzerland
- Age at study initiation:12 weeks
- identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
- randomization: Selected by hand at time of delivery. No computer generated randomization program.
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding (’Lignocel’ Schill AG, CH-4132 Muttenz Switzerland).
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 4/03 (Provimi Kliba AG, CH-4303 KaiseraugsVSwitzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum):Community tap water from Fullinsdorf ad /jbjtum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with target ranges for room temperature 22 +/- 3 °C and for relative humidity between 30-70%. (values above 70 % during cleaning process possible), 12 hours fluorescent light/12 hours dark, music during the light period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Three female rats received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for approximately 18 hours (access to water was permitted). Food was provided again 3 hours after dosing.

The application volume was 10 ml/kg body weight.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs were observed during the course of the study.
Body weight:
One female animal showed a loss of body weight (0.6 %) between test day 8 and the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of ucb 6474 after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight

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